SpoonfulOne launches virtual trial to study real-world applications of early food allergen introduction

By Mary Ellen Shoup contact

- Last updated on GMT

Photo: SpoonfulOne
Photo: SpoonfulOne

Related tags: Food allergies, SpoonfulOne

Food allergy protection company, SpoonfulOne, and the Duke Clinical Research Institute, are launching a digital randomized controlled trial recruiting 1,500 healthy babies to investigate the feasibility of early allergen introduction.

Food allergies have more than doubled over the last generation and today, six million children (or roughly two children per classroom) have a food allergy, according to FARE food allergy facts statistics from 2018.  

Based on the research from the LEAP​ and EAT​ studies showing that introducing a diverse mix of ingredients into a baby’s diet dramatically reduced levels of allergy-triggering antibodies, each serving of a SpoonfulOne​ products includes food groups responsible for over 90% of food allergies.

In addition, in an independent study​ conducted at Northwestern University Feinberg School of Medicine of over 700 infants and more than 8,000 feedings of SpoonfulOne, there were zero reported allergic reactions, reported the company.  

“We already know, based on global, landmark research that food allergy protection is more than possible, it's essential,"​ said SpoonfulOne chief medical officer and pediatrician, Dr. Wendy Sue Swanson.

SpoonfulOne products

Available through its website and on Amazon, SpoonfulOne products include three different product lines – mix-in powders, puffs, and oat crackers – catering to babies (4-months-old), ‘crawlers’ (6-months-old), and toddlers (12+-months-old).

SpoonfulOne products are now available globally through a partnership with Nestlé Health Science in which Nestlé acquired the non-US rights in 2019 to commercialize SpoonfulOne around the world.

SpoonfulOne_products

Gathering real-world parent experiences with early allergen introduction

The trial, which is expected to begin in December 2020, will support new feeding guidelines recommending the early introduction of potential food allergens for food allergy prevention while gathering parental experiences of early allergen introduction.

"Our understanding of food allergy protection has grown by leaps and bounds in the past few years, with landmark studies establishing the importance and safety of early introduction and sustained feeding of a diverse diet,” ​said principal investigator of the study and pediatric allergist, Dr. David Jeong.

However, we know in a real-world setting, it may not be so easy to accomplish. The results of this study have the potential to show how a comprehensive commercial food product can help make food allergy prevention easy for parents."

Study design and methods during COVID-19

Participants will be parents of healthy, full-term babies without a diagnosis of food allergy. The study will recruit to fill 30% of the participants with a diagnosis of eczema, as those babies are at the highest risk for developing food allergies, researchers said.

Participants will be 1:1 randomized between the intervention and control group. The active serving arm (n=750) will receive SpoonfulOne products once daily by mouth for 18 months. The control arm (n=750) will be fed on a standard diet only, without SpoonfulOne for 12 months.

“The objective is to investigate the ability of parents to protect their babies from developing food allergies by getting common food allergens into the diet routinely throughout infancy and toddlerhood,”​ said the company.

The siteless study will be conducted using a mobile platform where participating parents will complete study questionnaires and e-dairies at their convenience directly through the mobile application.

To complete the study, participants will receive SpoonfulOne products in the mail and complete app-based education modules, surveys, and inputs for data collection.

No in-person study visits are required, noted researchers.

"Our hypothesis is that we can employ digital health tools and solutions to confirm a reduction in sensitization and subsequent development of food allergy in infants as a result of proactively feeding common allergens leveraging SpoonfulOne,”​ said Dr. Swanson.

The third-annual virtual FOOD FOR KIDS summit​ is quickly approaching! Check out the online event’s impressive list of speakers​, ​and join the conversation by registering TODAY​.

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